Posts Tagged: Sandoz Inc.


CAFC sides with Sandoz, Amgen’s state claims preempted by BPCIA

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar …
By Aubrey Haddach
4 years ago 1

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

CAFC Finds Substantially Pure Isomer Obvious From Prior Art 50/50 Mixture

The issue on appeal was whether a mixture comprising at least 92% of the (6S) isomer of leucovorin would have been obvious when both the 50/50 mixture of isomers …

Federal Circuit Review – Issue 61 – July 31, 2015

Amgen filed a biologics license application (“BLA”) and obtained FDA approval for its filgrastim product, Neupogen. Sandoz subsequently filed an abbreviated BLA (“aBLA”) under 42 U.S.C. § 262(…